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This policy establishes guidelines for the use and disclosure of identifiable health information for purposes of research by UAB/UABHS Covered Entities in compliance with the Health Insurance Portability and Accountability Act (“HIPAA”) and Alabama state law.

This policy defines the UAB employee classification/status of a UAB employee who may serve as a principal investigator on externally sponsored grants and contracts. This policy will also help OSP’s user community understand why, in certain cases, the PI of record for the funding entity may not be the PI of record for UAB. For example, on certain training or fellowship grants, UAB designates the mentor as the PI, whereas NIH designates the student as the PI.

Clinical investigations involving human subjects and drugs, biologics, devices or test articles are subject to review. In order to comply with federal regulations, the IRB will determine what types of applications and exemptions (when applicable) are required for the study. This document describes various types of studies and instructions for submission and compliance.

This policy requires the implenmentation of a quality assurance and quality improvement program to monitor compliance with federal regulations and improve the Human Research Protection Program processes